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Phase I/II Trial of Human Leukocyte Antigen (HLA)-A*02:01-restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Conventional Dose of Gemcitabine for Advanced Pancreatic Cancer


Phase 1/Phase 2
20 Years
85 Years
Not Enrolling
Both
Pancreatic Cancer, Pancreas Neoplasms

Thank you

Trial Information

Phase I/II Trial of Human Leukocyte Antigen (HLA)-A*02:01-restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Conventional Dose of Gemcitabine for Advanced Pancreatic Cancer


HLA-A*02:01-restricted VEGFR1-specific cytotoxic T lymphocyte (CTL) responses were obtained
from HLA-A2/Kd transgenic murine model.

HLA-A*02:01-restricted VEGFR1-specific CTL clones were also obtained from peripheral blood
mononuclear cells of healthy volunteer donors.

These CTL clones showed potent anti-tumor CTL responses in HLA class Ⅰ-restricted manner in
vitro.

Vaccination of HLA-A*02:01-restricted VEGFR1-specific peptide to A2/Kd transgenic mice
markedly suppress the tumor-induced angiogenesis and tumor growth in vivo.


Inclusion Criteria:



- Heterozygote or homozygote of HLA-A*02:01 allele

- Inoperable or recurrent pancreatic cancer with or without any prior therapy

- Difficult to continue the prior therapy due to treatment-related toxicities

- ECOG performance status 0-2

- Evaluable primary or metastatic lesion with RECIST v.1.0 criteria

- Clearance period from prior therapy more than 4 weeks

- Life expectancy more than 3 months

- Laboratory values as follows 2,000/μL< WBC <15,000/μL Platelet count >100,000/μL AST
<150 IU/L ALT <150 IU/L Total bilirubin <3.0 mg/dl Serum creatinine <3.0 mg/dl

Exclusion Criteria:

- Pregnancy (refusal or inability to use effective contraceptives)

- Breastfeeding

- Active or uncontrolled infection

- Systemic use of corticosteroids or immunosuppressants

- Uncontrollable brain metastasis and/or meningeal infiltration

- Unhealed external wound

- Possibilities of complicated paralytic ileus or interstitial pneumonitis

- Decision of not eligible determined by principal investigator or attending doctor

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events

Outcome Description:

Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Naohide Yamashita, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Director, Research Hospital, Institute of Medical Science, Tokyo University

Authority:

Japan: Ministry of Education, Culture, Sports, Science and Technology

Study ID:

IMSUT-PPKVEGFR10201

NCT ID:

NCT00683085

Start Date:

May 2008

Completion Date:

May 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreas Neoplasms
  • cancer
  • pancreas
  • advanced
  • peptide
  • vaccination
  • VEGFR1
  • HLA
  • gemcitabine
  • IFA
  • Cancer of Pancreas
  • Neoplasms, Pancreas
  • Pancreas Cancer
  • Neoplasms
  • Pancreatic Neoplasms

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